510(k) K101212

MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R by Medtronic, Inc. — Product Code KRH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2010
Date Received
April 30, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ring, Annuloplasty
Device Class
Class II
Regulation Number
870.3800
Review Panel
CV
Submission Type